Complete Response Letter for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough – Merck

Merck Inc., known as MSD outside of the United States and Canada, announced that the FDA has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults . In the CRL, […]

Researchers find association between vaping and asthma among US adolescents

A new study from the Texas A&M University School of Public Health suggests that vaping increases the risk of asthma in adolescents who have never smoked conventional tobacco products. Vaping, or the use of electronic cigarettes (e-cigarettes), among adolescents has grown dramatically over the past several years. Although e-cigarettes have fewer toxins than regular cigarettes, they still contain a mixture of harmful […]

Nicotine e-cigarettes, prescription drugs and dual nicotine replacement therapy identified as most effective stop-smoking aids

Nicotine e-cigarettes and two prescription medications that curb symptoms of withdrawal are the most effective stop-smoking aids, according to a comprehensive, multinational review by a team of scientists, including a University of Massachusetts Amherst public health and health policy researcher. Dual forms of nicotine replacement therapy (NRT), such as combining a patch with gum or a lozenge, were found to […]

First RSV vaccine to protect infants and older adults

EU medicines regulators have approved a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is the first RSV vaccine indicated for passive immunisation of infants from birth through 6 months of age following administration of the vaccine to the mother during pregnancy. This vaccine is also indicated for active immunisation of adults aged 60 years […]

CHMP recommends Abrysvo the first RSV vaccine to protect infants up to 6 months of age and older adults – Pfizer

The CHMP has recommended granting a marketing authorization for Pfizer’s Abrysvo (bivalent, recombinant), a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is the first RSV vaccine indicated for passive immunization of infants from birth through six months of age following administration of the vaccine to the mother during pregnancy. It is also indicated for […]

CHMP recommends Lyfnua as a treatment for refractory or unexplained chronic cough – Merck Inc

Merck Inc., known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, developed for the treatment for adults with refractory or unexplained chronic cough. The CHMP’s recommendation will now be […]

MHRA (UK) approves Arexvy for prevention of lower respiratory tract disease caused by respiratory syncytial virus in adults 60 years of age and older – GSK

GSK plc announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. This is the first time an RSV vaccine for older adults has been authorised […]

European Commission approves Opdivo + chemotherapy for neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients with tumor cell PD-L1 expression greater than 1% – BMS

Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients with tumor cell PD-L1 expression greater than 1%. With this EC decision, Opdivo with chemotherapy becomes the first neoadjuvant immunotherapy-based treatment option approved […]

MAA submitted to the European Medicines Agency for approval of single tablet combination therapy of macitentan and tadalafil for treatment of pulmonary arterial hypertension – Jansen Pharmaceuticals

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of a single tablet combination therapy of macitentan 10 mg and tadalafil 40 mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients of […]

EU approves Arexvy for respiratory syncytial virus – GSK

GSK announced that the European Commission has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. This is the first time an RSV vaccine for older adults has been granted European Marketing Authorisation. The first launches […]